Description:
Vasectomy is an established procedure for male sterilization. Common techniques vary according to access to the vas deferens (scalpel vs. no scalpel), interruption of the vas and management of the vasal ends. Ligation and excision of a small segment of the vas is a common method of interruption. Techniques for managing the vasal ends include cautery of the vas lumen, fascial interposition or metallic clips. The VASCLIP^® device is a polymeric clip specifically designed for vasectomy that received U.S. Food and Drug Administration (FDA) clearance in 2002 through the 510(k) process. The FDA-approved intended use is "for ligation of the vas deferens." The device, which is about the size of a grain of rice, is placed on the intact vas and locked into place, thus eliminating the need for managing the vasal ends. Complications of vasectomy include occlusion failure, hematoma, infection, sperm granuloma, epididymitis and procedural pain.

Policy:
Vasectomy using a polymeric clip is considered INVESTIGATIONAL.

Policy Guidelines
CPT code 55450 describes ligation of vas deferens. It is unlikely that the use of a polymeric clip would be associated with an increase in physician work. Therefore, identification of vasectomy procedures using a polymeric clip would likely be identified through facility charges specifically for the polymeric clip.

Rationale
A MEDLINE literature search did not identify published data specifically on the recently available VASCLIP device. The informational material posted on the manufacturer’s website states that the VASCLIP device is associated with decreased pain and complication rates compared to other conventional vasectomy methods .¹ In addition, a 124-patient clinical study is described, reporting decreased rates of hematoma, infection and sperm granuloma compared to historical controls reported in the literature. In the absence of published peer-reviewed literature, the effectiveness of the VASCLIP device, either alone or in comparison to other vasectomy techniques, cannot be determined. The manufacturer also states that the vasectomy using the VASCLIP device may be more easily reversible. However, there are no data available on this potential advantage.

A literature search performed through October 2004 did not identify any additional published articles focusing on VASCLIP device. The literature search also focused on articles reporting data on the success rates of various different techniques of vasectomy. Several review articles noted the difficulties in assessing the outcomes of vasectomy. For example, there are different definitions of success; i.e., attainment of azospermia versus presence of immotile sperm. Pregnancy is, of course, a visible sign of failure, but pregnancy is also related to the fertility of the female, and proof of paternity is another complicating issue. Failure can be subdivided into early and late failure; early failure is attributed to technical issues, while late failure represents recanalization of the vas deferens. Given these limitations, in general, early failure rates of vasectomy (based on results of semen analysis) are estimated at less than 1%, while early complications, such as hematoma, infection, sperm granulomas or epididymitis, occur in 1 percent – 6 percent of men.² Other studies have examined pregnancy rates after vasectomy. For example, the U.S. Collaborative Review of Sterilization (CREST) study is a prospective, multicenter, observational study of sterilization that reported on the pregnancy rates among a cohort of women whose husbands underwent vasectomy.³ Among the 540 eligible women at risk for pregnancy, six pregnancies occurred from six to 72 weeks after vasectomy. The cumulative probability of failure per 1,000 procedures was 9.4 at one year after vasectomy and 11.3 at years two, three and five. While this review provides baseline data for the effectiveness of conventional vasectomy, there are inadequate data in the published peer-reviewed literature to document whether use of the VASCLIP devices provides an equivalent or superior outcome.

2006 Update
A literature review of the MEDLINE database performed for the period of 2005 through January 2006 did not identify any new published literature; therefore, the policy statement is unchanged.

2007 Update
A literature review was done using MEDLINE from January 2006 through May 2007. The clinical study described above has been published.⁴ This was a single-institution study of 124 consecutive patients who received the VASCLIP device. Successful sterilization was described per the study protocol in 116 of 119 patients (97 percent). In the three patients with persistent presence of sperm, histological examination after standard vasectomy indicated that misalignment of the device led to partial vas incision and recanalization. Levine and colleagues reported on a series of just eight patients who received VASCLIP. In this series, two of the eight patients failed vasectomy. Pathological analysis suggested that sperm extravasation and fistula tract formation was mechanisms for failure. Comparative trials with both adequate sample size and post-procedure testing are required to adequately evaluate this device. The current policy statement is unchanged; this approach is considered investigational.

2008–2009 Update
The policy was updated with a literature review using MEDLINE through November 2008. No new clinical studies involving this device were identified.

**Vasectomy is an elective technique of male sterilization that may be subject to benefit restrictions or exclusions.**

State or federal mandates (e.g., the FEP) may dictate that all devices approved for marketing by the U.S. Food and Drug Administration (FDA) may not be considered investigational, and, thus, these devices may be assessed only on the basis of their medical necessity. It should be noted that the issue is the medical necessity of the polymeric clip as opposed to the medical necessity (or coverage eligibility) of vasectomy as a whole.

References: 

1. Schwingl PJ, Guess HA. Safety and effectiveness of vasectomy. Fertil Steril 2000; 73(5):923-36.
2. Jamieson DJ, Costello C, Trussell J et al. The risk of pregnancy after vasectomy. Obstet Gynecol 2004; 103(5 pt 1):848-50.
3. Kirby D, Utz WJ, Parks PJ. An implantable ligation device that archieves male sterilization without cutting the vas deferens. Urology 2006; 67(4):807-11.
4. Levine LA, Abern MR, Lux MM. Persistent motile sperm after ligation band vasectomy. J Urol 2006; 176(5):2146-8.

Coding Section 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology ^© American Medical Association. All Rights Reserved"  

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